←Parkinson Disease
Study register · detail RCT · Parkinson Disease · 2021

Cannabidiol for Rapid Eye Movement Sleep Behavior Disorder

de Almeida et al. ·Movement Disorders Impact 3.9
No benefit demonstrated GRADE Moderate 66 citations
Samplen = 33 Pat.
Duration14 weeks
ControlMatched placebo capsules
EndpointRBD frequency / CGI-I / CGI-S
Blindingdoppelblind
DesignRCT
Cannabinoidcbd
Max. dose300.0 mg
Routeoral
Key finding

CBD showed no difference to placebo in the primary endpoints (frequency of nights with RBD, CGI-I, CGI-S); only temporary improvement in sleep satisfaction in weeks 4-8 at the 300mg dose.

Summary

n=33 Parkinson's patients with REM sleep behavior disorder (RBD), randomized 1:1 to CBD (75–300 mg) vs. placebo over 14 weeks. Primary outcomes (frequency of RBD nights, CGI-I, CGI-S): no difference CBD vs. placebo. Secondary outcome: significant improvement in sleep satisfaction with 300 mg CBD vs. placebo at week 4–8 (p=0,049 and p=0,038 respectively).

P
PopulationPatients with REM sleep behavior disorder (RBD) and Parkinson's disease, n=33
I
InterventionCannabidiol (CBD) oral, 75–300 mg/day, as add-on therapy
C
ControlMatched placebo capsules
O
OutcomeNo significant difference between CBD and placebo for primary endpoints (RBD frequency, CGI-I, CGI-S); secondary significant improvement in sleep satisfaction at week 4 (p=0,049) and week 8 (p=0,038) under CBD 300 mg
Confidence in the evidence
Moderate

The third of four GRADE levels, the effect estimate is probably reliable.

Downgraded for
Imprecision
Quality profile
Sample size ★★★★★
Blinding Double-blind
Effect size No benefit
Citations / year ★★★★★
Authors
de Almeida C M, Brito M M, Bosaipo N B et al.
DOI 10.1002/mds.28577↗
Design: RCT
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Abstract
Background: REM sleep behaviour disorder (RBD) is a common non-motor feature of Parkinson's disease (PD). Cannabidiol (CBD) is one of the main non-psychoactive components of Cannabis sativa and may represent an alternative route for treating Rbd. Objective: This study assessed the efficacy and safety of CBD for RBD in Pd. Methods: We conducted a phase II/III, double-blind, placebo-controlled clinical trial in 33 patients with RBD and PD. Patients were randomized 1:1 to CBD in doses of 75 to 300mg or matched capsules placebo and were followed up for 14 weeks. The primary outcomes were the frequency of nights with RBD, CGI-I, and Cgi-S. Results: CBD showed no difference to placebo for primary outcomes. Regarding secondary outcomes, we observed a significant improvement in average sleep satisfaction from the 4th to 8th week in the CBD versus placebo group with P = 0.049 and P = 0.038, respectively. Conclusion: CBD, as an adjunct therapy, showed no reduction in RBD manifestations in PD patients. A transient improvement in sleep satisfaction with a dose of 300mg has been noted. (c) 2021 International Parkinson and Movement Disorder Society.
Indication
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Mixed RCT

Phase-II-RCT, n=47 Parkinson-Patienten mit stabiler Motorik aber störenden Non-Motor-Symptoms (NMS, MDS-UPDRS-I ≥4). Open-label Nabilone-Titration (0,25–1 mg 2×/d), dann Randomisierung Responder zu Nabilone vs. Placebo (n=19). Primärer Endpunkt MDS-UPDRS-I nach 4 Wochen: Placebo-Gruppe verschlechterte sich um 2,63 Punkte (95% CI 1,53–3,74, p=0,002), Nabilone-Gruppe nur um 1,00 Punkte (95% CI −0,16–2,16, p=0,280); Differenz 1,63 Punkte (95% CI 0,09–3,18, p=0,030, Effektgröße 0,66). Positive Effekte v.a. auf Angst und nächtliche Schlafprobleme. 77% AEs in Titrationsphase (meist transient), keine schwerwiegenden AEs.

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The impediment to action advances action. — Marcus Aurelius